Tuesday, May 26, 2020

Binding Antibodies, nonneutralizing antibodies (n-NAbs), and Neutralizing Antibodies (NAbs)

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Last Monday, Moderna announced the positive results from its phase I clinical trial for its mRNA vaccine against Covid-19. The study was lis...
1 comment:
Sunday, May 24, 2020

Pre, During, and Post Pandemic: what are the cut points for defining pandemic start/end?

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The Covid-19 pandemic will have a lasting impact on clinical trials. The way how the clinical trials are conducted will forever be chang...
Thursday, May 07, 2020

Human Challenge Study Design for Covid-19 Vaccine Clinical Trials?

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The world is desperate to develop vaccines for Covid-19. Pharmaceutical and biotechnology companies are racing to start the clinical trials ...
Sunday, May 03, 2020

Interpreting Hazard Ratio: Can we say "percent reduction in risk"?

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For time to event variable, the most commonly used statistics is hazard ratio. Hazard ratio is the ratio of hazards and equals to the hazard...
5 comments:
Wednesday, April 22, 2020

For multi-center, open label clinical trials, can individual investigation sites disclose results from their sites while study is ongoing?

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The golden standard for clinical trials is RCT (randomized, control trials) including three key components: randomization, including a contr...
1 comment:
Thursday, April 09, 2020

Gilead's Remdesivir Clinical Trials - What Do Drastic Design Changes Mean?

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In the midst of the Covid-19 pandemic, people are rushing to find effective treatments for Covid-19 infected patients. Among the drugs being...
Monday, March 30, 2020

Gliead asked FDA to rescind the orphan drug designation for coronavirus treatment remdesivir it just received 48 hours earlier - Why?

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Last Monday, Gilead received the orphan drug designation from US FDA for remdesivir to treat Covid-19. Two days later on Wednesday, we saw ...
Sunday, March 29, 2020

Six Pivotal Studies Investigating the Efficacy of Remdesivir: Does Calling it Phase II or III Matter?

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During the Covid-19 pandemic, people are desperate to find effective treatments to combat the coronavirus. One promising drug is Gilead'...